Search Results (18)

Filtration surgery is highly effective in lowering intraocular pressure; however, it is associated with a higher risk of severe complications. Visual dysfunction may persist in relatively uneventful cases because of induced astigmatism or worsening optical aberrations. Therefore, for early- to moderate-stage glaucoma, an increasing number of surgeons are prioritizing surgical safety and preserving postoperative visual function by opting for minimally invasive glaucoma surgery (MIGS). Among the various MIGS techniques, canal-opening surgery—targeting aqueous outflow through the Schlemm’s canal (Schlemm’s canal-based MIGS, CB-MIGS)—has gained increasing popularity. Unlike filtration surgery, CB-MIGS does not require creating an aqueous outflow pathway between the intraocular and extraocular spaces. Consequently, it is considered a minimally invasive procedure with a reduced risk of severe complications and is increasingly being chosen for suitable cases. Although this surgical technique has limitations in lowering intraocular pressure, it avoids the manipulation of the conjunctiva or sclera and is primarily performed through a small corneal incision. Therefore, a minimal impact on induced astigmatism or postoperative refractive changes is expected. However, few reviews comprehensively summarize postoperative changes in visual function. Therefore, this study reviews the literature on visual function after CB-MIGS, focusing on changes in best-corrected visual acuity (BCVA), refraction, astigmatism, and the effectiveness of visual field preservation to assess the extent of these postoperative changes. Hyphema is the primary cause of early postoperative vision loss and is often transient in cases in which other complications would have led to visual impairment. Severe complications that threaten vision are rare. Additionally, compared with filtration surgery, postoperative visual recovery tends to be faster, and the degree of induced astigmatism is comparable to that of standalone cataract surgery. When combined with cataract surgery, the refractive error is at the same level as that of cataract surgery alone. However, in some cases, mild hyperopic shifts may occur because of axial length shortening, depending on the extent of intraocular pressure reduction. This possibility has been highlighted in several studies. Regarding the effectiveness of slowing the progression of visual field defects, most studies have focused on short- to medium-term postoperative outcomes. Many of these studies have reported the sufficient suppression of progression rates. However, studies with large sample sizes and long-term prospective designs are limited. To establish more robust evidence, future research should focus on conducting larger-scale, long-term investigations. Full article

Background/Objectives: To evaluate the long-term efficacy and safety of canaloplasty and phacocanaloplasty in patients with primary open-angle glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG). Methods: This retrospective observational study included 85 patients with POAG and PEXG who underwent canaloplasty (group 1) or phacocanaloplasty (group 2). Every patient had complete medical records over a 10-year follow-up period. The primary endpoints were the pressure-lowering and drug-sparing effects. The secondary endpoints were intra- and postoperative complications as well as the need for additional surgical interventions. Results: In group 1, the mean baseline intraocular pressure (IOP) of 22.1 ± 0.9 mmHg was reduced to 15.3 ± 0.5 mmHg, 15.7 ± 0.5 mmHg, and 15.9 ± 0.7 mmHg at 1, 5, and 10 years, respectively. The mean medication use decreased from 2.4 ± 1.0 before surgery to 0.1 ± 0.5, 0.8 ± 1.1, and 1.4 ± 1.3 at 1,5, and 10 years, respectively. In group 2, IOP was reduced from 20.4 ± 1.5 to 15.6 ± 1.0, 14.3 ± 0.8, and 14.2 ± 1.2 at 1, 5, and 10 years, respectively. The mean medication use dropped from 2.4 ± 1 to 0.3 ± 0.9, 0.9 ± 1.4, and 0.8 ± 1.1 at 1,5, and 10 years, respectively. Goniopuncture was performed postoperatively in nine cases (13.9%) within the initial 3 months due to IOP spikes (POAG n = 6, PEXG n = 3). Patients with PEXG had a significantly higher likelihood of requiring re-operation (HR = 5.11, HR = 5.11, 95% CI 1.05–24.74, p = 0.043). No serious complications were observed. Conclusions: Canaloplasty is a safe and effective procedure for lowering IOP in eyes with POAG and PEXG, achieving approximately a 30% reduction in IOP. PEXG patients are likelier to have IOP spikes in the late postoperative period therefore careful monitoring and management is required. Full article

Background/Objectives: Glaucomatous neuropathy, a progressive deterioration of retinal ganglion cells, is the leading cause of irreversible blindness worldwide. While elevated intraocular pressure (IOP) is a well-established modifiable risk factor, increasing attention is being directed towards IOP-independent factors, such as vascular alterations. Color Doppler imaging (CDI) is a prominent technique for investigating blood flow parameters in extraocular vessels. This prospective, nonrandomized clinical trial aimed to assess the impact of ab externo canaloplasty on ocular blood flow parameters in patients with primary open-angle glaucoma (POAG) at a three-month follow-up. Methods: Twenty-five eyes of twenty-five patients with early or moderate POAG underwent canaloplasty with simultaneous cataract removal. CDI was used to measure peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI) in the ophthalmic artery (OA), central retinal artery (CRA), and short posterior ciliary arteries (SPCAs) before and after surgery. Results: The results showed a significant reduction in IOP and improvement in mean deviation at three months post-surgery. Best corrected visual acuity and retinal nerve fiber layer thickness significantly increased at each postoperative control visit. However, no significant changes were observed in PSV, EDV, and RI in the studied vessels. Conclusions: In conclusion, while canaloplasty effectively reduced IOP and medication burden, it did not significantly improve blood flow parameters in vessels supplying the optic nerve at three months post-surgery. Careful patient selection considering glaucoma severity and vascular risk factors is crucial when choosing between canaloplasty and more invasive procedures like trabeculectomy. Further larger studies are needed to comprehensively analyze this issue. Full article

Glaucoma is one of the primary causes of blindness worldwide. Canal opening surgery, a type of minimally invasive glaucoma surgery (MIGS) applied in cases of mild to moderate glaucoma, has gained increasing popularity in recent years due to its efficacy in reducing the intraocular pressure, its safety profile, the simplicity of its technique, and the reduced likelihood of compromised vision. Nevertheless, the existing body of histopathological studies remains insufficient for a comprehensive understanding of post-surgical wound healing. Consequently, debates persist among researchers regarding the mechanism through which Schlemm’s canal opening surgery reduces the intraocular pressure, as well as the surgical techniques that may impact the outcomes and the factors influencing surgical success. As the history of MIGS is relatively short and lacks sufficient systemic reviews or meta-analyses evaluating the influence of individual factors, this review was conducted to illuminate the disparities in researchers’ opinions at the current stage of research. Full article

Background: This is a report of 3-year results of a prospective assessment of three modifications of canaloplasty (C): ab externo (ABeC), mini-canaloplasty (miniABeC), and ab interno (ABiC) performed concomitantly with cataract removal in subjects suffering from primary open-angle glaucoma (POAG). Methods: Forty-eight individuals were randomized for one of the surgeries: ABeC, miniABeC, or ABiC and cataract removal—16 eyes for each group. Follow-up examinations were carried out on the day of the surgery, on days 1 and 7, after 1, 3, 6 months, and at 1, 2, and 3 years. Complete and qualified success was an IOP ≤ 15 mmHg without or with antiglaucoma eye drops, respectively. The IOP reduction of 20% or more was considered an additional success criterion. Results: Within three years the probability of qualified success was ABiC and miniABeC—94%, ABeC—100%, and of complete success ABiC—75%, miniABeC—100%. At the 3-year follow-up, the median IOP decreased from 22 to 15 mmHg in the ABeC group (p = 0.001), from 22 to 15 mmHg in the miniABeC group 15 (p < 0.001), and from 21 to 15 mmHg in the ABiC group (p = 0.001) compared to the post-washout stage. The IOP dropped by 20% or more without medications in 56.2% of patients post ABiC, 68.8% post miniABeC and 75% post ABeC. The median number of antiglaucoma medications dropped in all three groups; at the 3-year follow-up, only one patient following ABeC and four subjects following miniABeC required treatment. One patient required reoperation and further intensification of topical treatment—post miniABeC. The levels of IOP, CDVA, and success probability at the 36-month follow-up showed no significant difference for individual groups. Conclusions: ABeC, miniABeC, and ABiC have significant IOP-lowering potential in individuals diagnosed with POAG at a mild to moderate stage and no history of IOP ≥ 30 mmHg with a good safety profile. Full article

This prospective, non-randomized, interventional clinical study evaluated the efficacy and safety profile of first-generation iStent bypass implantation versus ab externo canaloplasty, both combined with phacoemulsification, in patients with primary open-angle glaucoma (POAG) after 12-month follow-up. A total of 138 patients with POAG and their 138 eyes (69 phaco-iStent and 69 phacocanaloplasty) were included. Postoperatively at 12 months, the mean intraocular pressure (IOP) decreased from 18.44 ± 3.88 to 15.51 ± 2.50 mmHg and from 17.20 ± 4.04 to 14.97 ± 2.37 mmHg in the phaco-iStent (PiS) and phacocanaloplasty (PC) groups, respectively (p = 0.480). In both groups, 35.7% achieved >20% IOP reduction from baseline. A total of 86% and 71.4% of the eyes were medication-free at 12 months in the PiS and PC groups, respectively. In both groups, all eyes showed improvement in best-corrected visual acuity compared with baseline and demonstrated similar safety profiles throughout the 12-month follow-up period. This study showed equal hypotensive effects of PiS and PC. Both procedures significantly reduced the IOP and the requirement for IOP-lowering medications for at least 12 months postoperatively, with no significant differences between the groups. Full article

Minimally invasive glaucoma surgery (MIGS) has emerged as a novel approach in the glaucoma treatment spectrum, offering a range of diverse procedures and devices aimed at reducing intraocular pressure (IOP). MIGS can be broadly classified into several categories: those that enhance trabecular outflow (Trabectome, iStent, Hydrus Microstent, Kahook Dual Blade, high frequency deep sclerotomy, and gonioscopy-assisted transluminal trabeculotomy), those that augment suprachoroidal outflow (CyPass Microstent and iStent Supra), those that target Schlemm’s canal (TRAB360 and the OMNI Surgical System, Streamline, and Ab Interno Canaloplasty), and conjunctival bleb-forming procedures (EX-PRESS Glaucoma Filtration Device, Xen Gel Stent and PreserFlo MicroShunt). MIGS is considered to have a shorter surgical time and fewer severe complications when compared to traditional glaucoma surgeries such as trabeculectomy and glaucoma drainage device implantation (Ahmed, Baerveldt, and Molteno valves). This literature review comprehensively examines the distinct MIGS devices and procedures, their underlying mechanisms, and clinical outcomes, emphasizing the importance of evaluating the efficacy and complications of each approach individually. As the field of MIGS continues to evolve, it is crucial to prioritize high-quality, long-term studies to better understand the safety and effectiveness of these innovative interventions in glaucoma management. Full article

For decades, trabeculectomy (TE) was considered the gold standard for surgical treatment of open-angle glaucoma owing to its powerful intraocular pressure (IOP)-lowering potency. However, owing to the invasive nature and high-risk profile of TE, this standard is changing, and minimally invasive procedures are becoming more preferable. In particular, canaloplasty (CP) has been established as a much gentler alternative in everyday life and is under development as a full-fledged replacement. This technique involves probing Schlemm’s canal with a microcatheter and inserting a pouch suture that places the trabecular meshwork under permanent tension. It aims to restore the natural outflow pathways of the aqueous humor and is independent of external wound healing. This physiological approach results in a significantly lower complication rate and allows considerably simplified perioperative management. There is now extensive evidence that canaloplasty achieves sufficient pressure reduction as well as a significant reduction in postoperative glaucoma medications. Unlike MIGS procedures, the indication is not only mild to moderate glaucoma; today, even advanced glaucoma benefits from the very low hypotony rate, which largely avoids a wipeout phenomenon. However, approximately half of patients are not completely medication-free after canaloplasty. As a consequence, a number of canaloplasty modifications have been developed with the goal of further enhancing the IOP-lowering effect while avoiding the risk of serious complications. By combining canaloplasty with the newly developed suprachoroidal drainage procedure, the individual improvements in trabecular facility and uveoscleral outflow facility appear to have an additive effect. Thus, for the first time, an IOP-lowering effect comparable to a successful trabeculectomy can be achieved. Other implant modifications also enhance the potential of canaloplasty or offer additional benefits such as the possibility of telemetric IOP self-measurement by the patient. This article reviews the modifications of canaloplasty, which has the potential to become a new gold standard in glaucoma surgery via stepwise refinement. Full article

Background: To evaluate the long-term efficacy and safety of modified canaloplasty versus trabeculectomy in open-angle glaucoma. Methods: In total, 210 subjects with open-angle glaucoma were included. 70 were treated with Mitomycin C-augmented modified canaloplasty with enhanced subconjunctival filtration and 140 with Mitomycin C-augmented trabeculectomy. Cases were matched 1:2 by sex and age. Results: In canaloplasty and trabeculectomy groups, 61.4% and 57.9% of participants were female. Mean age was 60.0 ± 13.9 and 63.0 ± 12.2 years, median follow-up time was 4.6 [IQR 4.3, 5.05] years and 5.8 [IQR 5.4, 6.3]. Strict success was achieved in 20.0% and 56.4%, complete success in 24.3% and 66.4%, and qualified success in 34.3% and 73.6% (each p < 0.001). Kaplan–Meier survival analysis showed a better survival probability for trabeculectomy than for canaloplasty (p < 0.001) and Cox regression analysis revealed an HR of 6.03 (95%-CI 3.66, 9.93, p < 0.001) after canaloplasty. Trabeculectomy showed superiority in terms of IOP decrease (9.2 ± 7.9 mmHg vs. 13.7 ± 10.4 mmHg, p = 0.002), use of AGM (50.0% vs. 10.7%, p < 0.001), and the number of revision surgeries (41.4% vs. 21.4%, p = 0.004). Occurrence of complications was similar in both groups (14.5% vs. 7.5%, p = 0.19). Conclusions: Trabeculectomy showed superiority in efficacy and equality in safety compared to modified canaloplasty. Full article

This study evaluated the early outcomes of the hypotensive efficacy and safety profile of ab externo phaco-canaloplasty versus first-generation iStent bypass implantation combined with phacoemulsification in patients with primary open-angle glaucoma (POAG). In total, 82 patients with POAG comprising 92 eyes were divided into phaco-canaloplasty (Group PC, (n = 47) or iStent combined with phacoemulsification (Group PiS, n = 45) groups. Primary outcome measures were intraocular pressure (IOP) reduction and number of glaucoma medications. Secondary outcome measures were best-corrected visual acuity (BCVA), endothelial cell density (EECD), changes in anterior chamber depth (ACD), and complication rate. The follow-up period was approximately 6 months. Preoperative IOPs were 17.30 (15.00; 19.85) mmHg and 17.50 (15.10; 20.90) mmHg in the PC and PiS groups, respectively (p = 0.876). At the end of the follow-up, IOP decreased to 15.00 (13.00; 16.00) mmHg and 15.00 (14.00; 17.00) mmHg in the PC and PiS groups, respectively (p = 0.438). Medication usage decreased from 2.08 to 0.12 and 1.40 to 0.04 in PC and PiS eyes, respectively. Most patients in both groups were medication-free at 6 months follow-up. After 6 months of observation, EECD in PC and PiS groups decreased from 2309.50 (2032.00; 2533.00) to 1966.50 (1262.00; 2353.50) and 2160.00 (1958.50; 2372.50), to1231.00 (1089.00; 2050.00), respectively (p = 0.037). Pre-surgery BCVA was 0.80 (0.50; 1.00) and 0.60 (0.40; 1.00) in PC and PiS eyes, respectively (p = 0.456). Follow-up BCVA was 0.95 (0.60; 1.00) for PC and 1.00 (1.00; 1.00) for PiS. Hyphema and corneal oedema were noted on the first day post-surgery in both groups. Subsequent complications included a transient increase in IOP in the PC group. Phaco-canaloplasty and iStent bypass implantation combined with phacoemulsification significantly lowered IOP and decreased medication burden. All eyes in both groups maintained or exhibited improved BCVA relative to baseline. Both surgeries had low postoperative complication rates and exhibited comparable safety profiles over 6-month follow-up in patients with POAG. Full article

Background: To evaluate and compare the visual function and the quality of life (QoL) in glaucomatous patients treated with topical medical therapy (TMT) alone, canaloplasty (CP), or trabeculectomy (TB). Methods: A total of 291 eyes of 167 patients with primary open-angle glaucoma or secondary pseudoexfoliative glaucoma in TMT or surgically treated with CP or TB were included. Eligibility criteria for surgical patients included not needing TMT after surgery. Each patient underwent a visual field assessment and peripapillary retinal nerve fiber layer (pRNFL) optical coherence tomography and filled out the Glaucoma Symptoms Scale (GSS) questionnaire and the 25-Item National Eye Institute Visual Functioning Questionnaire (25-NEI-VFQ). Comparison between the QoL level of the three groups and its correlation with optic nerve’s anatomical and functional status was the primary outcome. Results: CP patients reported the best general vision (p = 0.01), a lower incidence of eye burning (p = 0.03), and the lowest annoyance level of non-visual symptoms (p = 0.006). QoL positively correlated with pRNFL thickness, whereas no correlation was found with visual field damage. Conclusion: CP provides a better QoL when compared both to TB and TMT, regardless of glaucoma stage. pRNFL seems to provide additional information for predicting change in QoL. Full article

Background: Schlemm’s canal (SC) targeted procedures constitute a promising therapy for open angle glaucoma (POAG), safer and less invasive. However, little attention was paid to the intraocular pressure (IOP) variation in patients receiving these procedures, which is the risk factor for POAG progression. This study is to evaluate the IOP variation in eyes with POAG after modified canaloplasty (MC) and microcatheter assisted trabeculotomy (MAT). (2) Methods: POAG with good IOP in office hours after MC or MAT and age-matched normal subjects were recruited in this prospective coherent study. IOP in sitting and supine positions and 24-h IOP was measured. Aqueous vein and blood reflux into the SC were examined. (3) Results: Among 20 normal subjects, 25 eyes with MC eyes and 30 eyes with MAT were recruited in this study. Aqueous veins are frequently located in the inferior nasal quadrants in all groups. No pulsatile signs were observed in an aqueous vein in the MAT group but they were observed in 68% of the MC group. Blood reflux in the SC could be seen in all the operated eyes. The IOP in the sitting position was not significant different among groups (p = 0.419). Compared to normal, the IOP increased dramatically after lying down for 5 min in the MC and MAT groups (PMC vs. normal = 0.003, PMAT vs. normal = 0.004), which is similar for IOP change after lying down for 60 min (PMC vs. normal < 0.001, PMAT vs. normal < 0.001). In terms of diurnal IOP, subjects were stable in the MAT group (p < 0.01), variable in the normal group (p = 0.002), and most fluctuant in MC group (p < 0.001). (4) Conclusions: MC and MAT reduce the IOP but present aberrant short-term IOP regulation, which should be paid attention to in clinical settings. Full article

Background: A single-center prospective randomized observational study to compare three types of canaloplasty, i.e., ab externo (ABeC), minicanaloplasty (miniABeC) and ab interno, (ABiC) combined with cataract surgery in primary open-angle glaucoma (POAG) patients over 12 months. Methods: 48 POAG patients underwent one of three canaloplasty procedures: ABeC (16 eyes), miniABeC (16 eyes) or ABiC (16 eyes) or combined with phacoemulsification. Patients were assessed at baseline, at day 0–1–7 and at month 1–3–6–12. Successful treatment was defined as unmedicated IOP reduction ≥20%. Complete surgical success was defined as an IOP ≤ 15 mmHg without medications, and a qualified surgical success as IOP ≤ 15 mmHg with or without medications. Results: Pre-washout IOP median values (mmHg) were 17 (ABeC), 18 (miniABeC) and 17 (AbiC) and decreased at 12-month follow up postoperatively to 13 (p = 0.005), 13 (p = 0.004) and 14 (p = 0.008), respectively—successful treatment was achieved in approximately 100% of patients for ABeC and in 93.8% for both miniABeC and AbiC groups. Preoperatively, the median number of medications was 2.0 (range 1–3) (ABeC), 2.0 (1–3) (miniABeC) and 2.0 (0–4) (ABiC); 12-month post-operatively, all medications were withdrawn except in two patients (followed miniABeC and AbiC). Conclusions: The three variants of canaloplasty significantly reduced IOP and the number of medications in patients with mild to moderate POAG and gave no significant complications. Full article

Postoperative restenosis in patients with external ear canal (EEC) atresia or stenosis is a common complication following canaloplasty. Our aim in this study was to explore the feasibility of using a three dimensionally (3D)-printed, patient-individualized, drug ((dexamethasone (DEX)), and ciprofloxacin (cipro))-releasing external ear canal implant (EECI) as a postoperative stent after canaloplasty. We designed and pre-clinically tested this novel implant for drug release (by high-performance liquid chromatography), biocompatibility (by the MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay), bio-efficacy (by the TNF-α (tumor necrosis factor-alpha)-reduction test (DEX) and inhibition zone test (for cipro)), and microbial contamination (formation of turbidity or sediments in culture medium). The EECI was implanted for the first time to one patient with a history of congenital EEC atresia and state after three canaloplasties due to EEC restenosis. The preclinical tests revealed no cytotoxic effect of the used materials; an antibacterial effect was verified against the bacteria Staphylococcus aureus and Pseudomonas aeruginosa, and the tested UV-irradiated EECI showed no microbiological contamination. Based on the test results, the combination of silicone with 1% DEX and 0.3% cipro was chosen to treat the patient. The EECI was implantable into the EEC; the postoperative follow-up visits revealed no otogenic symptoms or infections and the EECI was explanted three months postoperatively. Even at 12 months postoperatively, the EEC showed good epithelialization and patency. Here, we report the first ever clinical application of an individualized, drug-releasing, mechanically flexible implant and suggest that our novel EECI represents a safe and effective method for postoperatively stenting the reconstructed EEC. Full article

Purpose: The aim of this study was to assess the long-term outcomes of canaloplasty surgery in pseudoexfoliation glaucoma (PEXG) patients. Material and Methods: A total of 116 PEXG patients with an intraocular pressure (IOP) > 21 mm/Hg and maximum tolerated local medical therapy who underwent canaloplasty from February 2008 to January 2022 were considered. Every six months, all subjects underwent a complete ophthalmic examination. The period of follow-up ranged from 2 to 167 months. Inclusion criteria included only patients for whom the entire procedure could be completed with a follow-up of at least 2 years. Results: Amongst the 116 PEXG patients, the entire procedure could not be performed in 10 eyes (8.6%), and thus they were not considered in the analysis. Twenty-three patients did not reach the two-year follow-up and another 16 patients during this time period were lost. A total of 67 patients with a mean follow-up of 49 ± 32.3 months were considered in the analysis. The pre-operative mean IOP was 31.2 ± 8.7 mm/Hg (range 20–60). The mean IOP at the two-year follow-up was 17.2 ± 6.7 mmHg, with a mean reduction from baseline of 44.9%. After two years, the qualified success rates according to three different criteria (IOP ≤ 21, ≤18 and ≤16 mmHg) were 80.6%, 73.1% and 61.0%, respectively. The total number of medications used pre- and at the follow-up at 2 years was 3.5 ± 0.8 and 1.2 ± 1.4, respectively. Early complications included: hyphema, in about 30% of cases; Descemet membrane detachment (4.9%); and IOP spikes > 10 mmHg (9.7%). A late failure with an acute IOP rise of up to 50 mmHg was observed in 41 cases (61.2%) after 3 to 72 months. Conclusions: Long-term post-operative outcomes of canaloplasty in PEXG patients appear to be quite good on average; however, an acute rise in IOP can be observed in more than 60% of the cases after a long period of satisfactory IOP control. For this reason, canaloplasty may not be suitable in eyes with PEXG, especially in patients with severe functional damage. Full article